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Plavix (Clopidogrel Bisulfate) - Summary

 
 



PLAVIX SUMMARY

PLAVIX (clopidogrel bisulfate) is an inhibitor of ADP-induced platelet aggregation acting by direct inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex.

PLAVIX (clopidogrel bisulfate) is indicated for the reduction of thrombotic events as follows:

  • Recent MI, Recent Stroke or Established Peripheral Arterial Disease
    For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, PLAVIX has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
  • Acute Coronary Syndrome
    For patients with acute coronary syndrome (unstable angina/non-Q-wave MI) including patients who are to be managed medically and those who are to be managed with percutaneous coronary intervention (with or without stent) or CABG, PLAVIX has been shown to decrease the rate of a combined endpoint of cardiovascular death, MI, or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia.


See all Plavix indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Plavix (Clopidogrel)

Clopidogrel trial in patients with elective percutaneous coronary intervention for stable angina and old myocardial infarction (CLEAN). [2012]
Clopidogrel in combination with aspirin has been widely used in patients who have undergone coronary stent implantation. However, the benefit to Japanese patients with stable angina (SA) or old myocardial infarction (OMI) undergoing percutaneous coronary intervention (PCI) still remains unclear.The aim of this multicenter, randomized, double-blind, clinical study was to evaluate the safety of a clopidogrel 300 mg loading dose followed by a 75 mg maintenance dose compared to ticlopidine 100 mg twice daily in patients with SA or OMI undergoing PCI who were on aspirin (81 to 100 mg once daily)...

Association of proton pump inhibitor use on cardiovascular outcomes with clopidogrel and ticagrelor: insights from the platelet inhibition and patient outcomes trial. [2012]
CONCLUSIONS: The use of a PPI was independently associated with a higher rate of

Reversal of clopidogrel-induced bleeding with rFVIIa in healthy subjects: a randomized, placebo-controlled, double-blind, exploratory study. [2011.10]
BACKGROUND: Clopidogrel (Plavix(R)) therapy, although effective for minimizing risk of thrombotic events, is also associated with potential bleeding risk. Recombinant activated FVII (rFVIIa, NovoSeven(R)) induces hemostasis in hemophilia patients with inhibitors (alloantibodies) and has been proposed as potential treatment for mitigating clopidogrel therapy-mediated bleeding... CONCLUSIONS: In this clinical study, rFVIIa (10 and 20 mug/kg) reversed the effect of clopidogrel on blood loss.

Effect of clopidogrel withdrawal on platelet reactivity and vascular inflammatory biomarkers 1 year after drug-eluting stent implantation: results of the prospective, single-centre CESSATION study. [2011.10]
CONCLUSION: An aspirin-independent, time-dependent increase in AA-induced platelet activation following clopidogrel withdrawal in patients with a DES has been described. New insights into a potential mechanism for the observed clustering of adverse events that occur early after clopidogrel cessation have been provided. These findings raise the question as to whether AA-induced clotting is an appropriate test of aspirin sensitivity.

Variability in response to clopidogrel: how important are pharmacogenetics and drug interactions? [2011.10]
Clopidogrel is a pro-drug which is converted to an active metabolite that selectively blocks ADP-dependent platelet activation and aggregation. The main enzyme responsible for activating clopidogrel is the cytochrome P450 (CYP) isoenzyme CYP2C19, which is polymorphic... This current review aims to summarize the role of pharmacogenetics and drug interactions in determining variability in response to clopidogrel.

more studies >>

Clinical Trials Related to Plavix (Clopidogrel)

Pharmacodynamics of CGT 2168 Compared With Plavix® [Active, not recruiting]
CG106 is a Phase I open-label, randomized, multiple-dose, two-way crossover study to characterize the pharmacodynamics and pharmacokinetics of the investigational fixed-dose combination product CGT 2168 (clopidogrel, 75 mg and omeprazole, 20 mg) relative to Plavix® (clopidogrel, 75 mg).

Healthy volunteer subjects will undergo two dosing periods. In each 7-day dosing period, subjects will receive oral doses of study drug consisting of open-label CGT 2168 or Plavix® in the order determined by the randomization schedule. Each period of dose administration will be separated by a two-week washout period. Study exit will occur 1 week after Dosing Period 2. The expected total duration of participation is 8 weeks (56 days), including a screening visit on or within 21 days prior to enrollment.

On the day before Day 1 and Day 7 in each dosing period, subjects will be admitted to the Phase I unit. Blood samples to determine ADP-induced platelet aggregation will be collected pre-dose on Day 1 and 2 h after dosing on Day 7. Plasma concentrations of clopidogrel parent and clopidogrel carboxylic acid metabolite will also be measured pre-dose on Day 1 and pre-dose and serially after dosing on Day 7.

Effect of Different Dosing Regimens of Clopidogrel Before Elective Percutaneous Coronary Intervention (PCI) on Platelet Function [Completed]
Adequate platelet inhibition before percutaneous coronary intervention (PCI) reduces peri-procedural and long-term ischemic complications. Documented reduced response to clopidogrel has been associated with subsequent major adverse cardiovascular events. Strategies to optimize platelet inhibition pre-PCI are under investigation.

This study sought to evaluate the effect on platelet aggregation of four different dosing regimens of clopidogrel given before elective PCI.

Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS [Completed]
Laboratory clopidogrel resistance is associated with adverse atherothrombotic events in patients with coronary artery disease. In the proposed study we wish to prospectively assess the effect of reloading with 600 mg clopidogrel, and administer maintenance treatment with clopidogrel 150 mg/day for one month in a group of acute myocardial infarction (AMI) patients who demonstrate non-responsiveness to clopidogrel.

Fasting Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's clopidogrel bisulfate 75 mg tablets to Bristol-Myers Squibb/Sanofi's Plavix® 75 mg tablets following a single, oral 75 mg (1 x 75 mg) dose administered under fasting conditions.

Food Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's clopidogrel bisulfate 75 mg tablets to Bristol-Myers Squibb/Sanofi's Plavix® 75 mg tablets following a single, oral 75 mg (1 x 75 mg) dose administered under fed conditions.

more trials >>

Reports of Suspected Plavix (Clopidogrel) Side Effects

Death (186)Gastrointestinal Haemorrhage (126)Dyspnoea (115)Anaemia (109)Myocardial Infarction (104)Contusion (90)Haemorrhage (74)Asthenia (72)Fall (70)Cerebrovascular Accident (68)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 4 ratings/reviews, Plavix has an overall score of 7.75. The effectiveness score is 8.50 and the side effect score is 8.50. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Plavix review by 65 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   R.A.
Dosage & duration:   200 mg taken twice per day for the period of 7 yrs.
Other conditions:   None
Other drugs taken:   Meloxicam 7.5 mg (Mobic)
  
Reported Results
Benefits:   This regimen eliminated, for the most part, the pain, stiffness, and exhaustion experienced with rheumatoid arthritis.
Side effects:   No side effects at all, other than returning me to an apparently more normal state of health.
Comments:   Initially, stronger drugs such as cortisone were needed to control and stabilize the rheumatoid arthritis. Once that was accomplished, the Plavix/Mobic treatment has been consistently effective for quite a few years.

 

Plavix review by 59 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   strokes
Dosage & duration:   75mg taken 1 per day for the period of About 5 years and continuing
Other conditions:   high bad cholesterol, elevated blood pressure
Other drugs taken:   ramapril, lipitor
  
Reported Results
Benefits:   Since starting the plavix and other meds, I have had no strokes.
Side effects:   Terrible bruising. If I bump my fingers, the joints will swell.
Comments:   I've had one stroke and 15 T.I.A.s. It is a genetic problem, but I have fully recovered from all. The first was in my 30's. I eat a very healthy, low fat, vegetarian diet and I excercise regularily. The meds I take are necessary, however a healthy, acitve lifestyle is critical.

 

Plavix review by 59 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   strokes
Dosage & duration:   75mg taken 1 per day for the period of About 5 years and continuing
Other conditions:   high bad cholesterol, elevated blood pressure
Other drugs taken:   ramapril, lipitor
  
Reported Results
Benefits:   Since starting the plavix and other meds, I have had no strokes.
Side effects:   Terrible bruising. If I bump my fingers, the joints will swell.
Comments:   I've had one stroke and 15 T.I.A.s. It is a genetic problem, but I have fully recovered from all. The first was in my 30's. I eat a very healthy, low fat, vegetarian diet and I excercise regularily. The meds I take are necessary, however a healthy, acitve lifestyle is critical.

See all Plavix reviews / ratings >>

Page last updated: 2013-02-10

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